Overall, 5.8 million individuals in the United States suffer from heart failure (HF) and one in ten elderly develops HF. Despite advances in treatment and relative improvement in survival, the rate of HF hospitalizations has surpassed one million yearly with HF becoming the leading hospital diagnosis for Medicare patients. The costs for HF care are close to $40 billion annually and this represents a large cost to the Medicare system. More than two-thirds of the costs are related to HF hospitalizations, as a result of suboptimal disease management, with roughly 25% of patients readmitted within 30-days of hospital discharge.
A major barrier in preventing HF related hospitalization is the current reactive standard of care, which involves relying on a patient self-reported daily weight to determine if a sudden increase in body fluid weight has occurred. Unfortunately, body weight has been shown to be an unreliable marker for cardiac decompensation, and suffers from very low patient compliance. It is worth emphasizing that the population of individuals who suffer from heart failure are predominantly elderly and thus have a very hard time following instructions, often forgetting their tasks or are unmotivated to follow instructions.
At least fifty percent (50%) of HF related hospitalizations are preventable, and that early detection of symptoms can led to a fifty-six percent (56%) reduction in mortality in this population, simple and reliable non-invasive methods to detect early HF decompensation are missing. New tools for HF outpatient monitoring and management can reduce its high morbidity.
Several studies conducted in HF patients that have cardiac implantable electronic devices (CIED) capable of monitoring physiologic parameters have shown that trending these parameters can predict a HF decompensation before it occurs. Unfortunately, such devices are used in less than a third of HF patients, require a surgical procedure to implant the device and need in home remote setup, adding to the complexity of the disease management process.